21 CFR 880.5475 — Lavage, Jet
General Hospital (HO) · Part 880 Subpart F—General Hospital and Personal Use Therapeutic Devices · § 880.5475
Identification
A jet lavage is a device used to clean a wound by a pulsatile jet of sterile fluid. The device consists of the pulsing head, tubing to connect to a container of sterile fluid, and a means of propelling the fluid through the tubing, such as an electric roller pump.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| FQH | Lavage, Jet | 2 | 53 |
Special Controls
FQH — Lavage, Jet
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
eCFR
